WinKQCL™ 5 Qualification Manual

Product Overview

WinKQCL^TM Installation, Operational, Performance Qualification  (IOPQ) Manual

The WinKQCL^TM Endotoxin Detection Qualification Manual includes the essential components to satisfy requirements when performing an installation, operational, and performance qualification of Lonza approved instruments to quantitate the endotoxin assay using Lonza reagents.

Features the IOPQ Manual qualify include:

  
• Integration of Molecular Devices^® SpectraMax^®, Gemini^TM and VersaMax^TM readers; BioTek^TM ELx808^TM, FLx800^TM, Eon^TM and Synergy^TM 2 readers; and the Tecan^® Sunrise^TM reader
   
   
• Enterprise level IT features including wide area network support, ability to work across time zones, application virtualization, Active Directory^® integration and data segregation by lab 
   
• Bi-directional interface with 3rd party database systems, such as Lonza’s MODA^TM Environmental Monitoring Software, or an LIS or LIMS system. Data can be pushed directly into the template and data can be exported out to 3rd party systems
   
• Tecan^® EVOware^® interface integration for PyroTec^TM Liquid Handling System
   
• Multi-user control:  multiple users can control multiple readers from one workstation
   
• Customizable endotoxin test reports
   
• Fine grain user permissions control
   
• Rapid data entry via barcode compatible windows
   
• Edit assay feature which allows for the correction of template layout mistakes
   
• Template customization with a click of a mouse using the SpeedFill^TM and Drag n’ Drop features
   
• Interactive trending tools provide actionable results on demand, helping you easily detect drift and enabling you to make proactive decisions. Trending is included in the WinKQCL^TM Software. No need to purchase a separate trending application.
   
• Built-in database backup and maintenance scheduler
   
• Meets 21 CFR Part 11 technical requirements for electronic records and signatures, audit trails and database archiving   
   
• Multi-language support for installation, user interface, reports and user help and manual: English, French, German, Italian, Japanese, Spanish, Portuguese, Simplified Chinese and Traditional Chinese  
   
• WinKQCL^TM Version 5.3.1 is now available. Please contact our Scientific Support Team for download and trial of our latest release 

Active Directory is a trademark of Microsoft Corporation. 

Molecular Devices, SpectraMax, VersaMax and Gemini are trademarks of Molecular Devices, LLC. 

BioTek, Synergy, ELx808, Eon and FLx800 are trademarks of BioTek Instruments, Inc. 

Tecan, EVOware and Sunrise are trademarks of Tecan Group Ltd.